Second win for Myriad as Federal Circuit stands firm on gene patent ruling

Managing IP is part of Legal Benchmarking Limited, 1-2 Paris Gardens, London, SE1 8ND

Copyright © Legal Benchmarking Limited and its affiliated companies 2026

Accessibility | Terms of Use | Privacy Policy | Modern Slavery Statement

Second win for Myriad as Federal Circuit stands firm on gene patent ruling

solated-dna-molecule-on-white-background-45.jpg

Biotech company Myriad, which owns US patents covering the isolation and detection of the BRCA1 and BRCA2 genes, has won a second victory at the US Court of Appeals for the Federal Circuit

In the long-running dispute, a number of parties including the Association for Molecular Pathology argued that Myriad’s claims covered matter that was not eligible for patent protection.

In today’s majority opinion, Judge Alan Lourie affirmed that the district court had declaratory judgment jurisdiction as at least one plaintiff (Harry Ostrer) had standing to challenge the validity of the patents.

The Federal Circuit also again reversed the district court’s finding that Myriad’s composition claims to isolated DNA molecules cover patent-ineligible products of nature saying “each of the claimed molecules represents a nonnaturally occurring composition of matter”

In addition, the court reversed the finding that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates of transformed cells is directed to a patent-ineligible scientific principle.

But it affirmed the district court’s decision that Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible, saying “such claims include no transformative steps and cover only patent-ineligible abstract, mental steps”.

Judge Kimberly Moore, who reportedly asked probing questions in the oral hearing, wrote a concurring opinion.

But Judge William Bryson wrote an opinion in which he dissented from the court’s holding that Myriad’s BRCA gene claims and its claims to gene fragments are patent-eligible.

“In my view, those claims are not directed to patentable subject matter, and the court’s decision, if sustained, will likely have broad consequences, such as preempting methods for whole-genome sequencing, even though Myriad’s contribution to the field is not remotely consonant with such effects,” wrote Bryson.

The Federal Circuit first ruled in the Myriad case in July last year, after which an appeal to the Supreme Court was filed. The case was remanded back to the Federal Circuit following the Supreme Court’s decision in Mayo v Prometheus in March this year.

The list of attorneys acting for the parties and amicus curiae extends to five pages of the opinion. One of them was Dan Ravicher of the Public Patent Foundation, who was profiled as one of the 50 most influential people in IP last month.

Managing IP also has a page devoted to the Myriad case.

more from across site and SHARED ros bottom lb

More from across our site

UPC cases are (very) gradually becoming more distributed across other local divisions outside Germany, which can only be good news for the pan-European forum
Clarification concerning jurisdictional reach and latest stats released by the court were also among the top talking points in recent weeks
Although unanimous decision by the top court clarifies several aspects of the honest concurrent use defence, practitioners say ambiguities remain
Tristan Sherliker says he hopes to solve an access to justice issue by making the automated court bundle tool free to use
The team, comprising two partners and one senior consultant, plans to offer “highly differentiated” services to clients
HGF’s new ownership model frees it from the hiring constraints of traditional partnerships, its CEO told Managing IP
New timeline for 2026 aims to provide clearer guidance to firms and practitioners on the full jurisdictional market view
Attorneys contemplate whether clients using AI for legal guidance is beneficial to attorney-client relationships or more of a nuisance
Richard de Bodo, who had a lengthy career at international firms, shares how he will address client needs and praises the unique offerings of smaller firms
An Australian top court decision clarifying honest concurrent use and wins by publishers against AI platforms were also among the top talking points
Gift this article